Stuart Hogarth

OUTLINE

Summary

64

Introduction

64

Concerns about genetic tests

65

Regulatory frameworks

67

Regulation of medical devices

68

Registration

68

Quality assurance

68

Pre-market review

69

Truth-in-labeling

69

Post-marketing controls

69

Limitations of current regimes for regulating genetic tests as medical devices 70

Laboratory-developed tests and medical device regulations 70

Risk classification 71

Post-marketing surveillance 72

Nutrition and Genomics

ISBN: 978-0-12-374125-7

Copyright © 2009, Elsevier Inc.

All rights reserved.

Regulation of clinical laboratories

73

Registration

73

Quality assurance

73

Pre-market review

73

Result reporting

74

Personnel

74

Limitations of current regimes for regulating clinical laboratories

performing genetic tests

74

Lack of proficiency testing

74

Regional/national variation in regulation

74

Focus on analytic performance

75

Lack of transparency

75

Recent developments in regulation

75

Regulation options

77

Pre-market review and post-market controls

77

Test and laboratory registry

78

Enhanced role for third parties

79

Consumer education

80

Conclusion

80

References

81

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